FDA Sent These 6 Warning Letters to Food Companies | May 2018

We took a snapshot of the 6 warning letters the FDA sent to food companies last month. Food violations ranged from companies failing to have personnel conform to hygienic practices while on duty to companies failing to clean and sanitize utensils. From companies in the Carolinas, New York, and more, here they are: Performance Nutrition Formulators LLC d.b.a. VMI [...]

By | 2018-06-11T15:06:09+00:00 June 11th, 2018|CGMP, FDA Warning Letters, Food, FSMA|

88 New FDA 483s | June 5th 2018

In the past 2 weeks we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free trial of the leading GMP intelligence newsletter. Like This & Want More? Sign up to get free weekly content updates designed to make your [...]

FDA Sent These 4 Warning Letters for Food Companies | April 2018

We took a snapshot of the 4 warning letters the FDA sent to food companies last month. Food violations ranged from products containing a poisonous or deleterious substance to companies failing to have an HACCP plan. From companies in Washington, Kansas, and more, here they are: Arrow Reliance Inc., Tukwila, Washington – 1 violation: Products are adulterated under section 402(a)(1) [...]

By | 2018-05-29T17:01:12+00:00 May 29th, 2018|CGMP, FDA Warning Letters, Food, FSMA|

96 New FDA 483s | May 21st 2018

In the past 2 weeks we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free trial of the leading GMP intelligence newsletter. Like This & Want More? Sign up to get free weekly content updates designed to make your [...]

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114 New FDA 483s | May 7th 2018

In the past 2 weeks we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free trial of the leading GMP intelligence newsletter. Like This & Want More? Sign up to get free weekly content updates designed to make your [...]

The Secret Life of (b)s

I recently discovered a gap in my education. Like you, I’ve seen my share of redacted 483s and EIRs. Those redactions are marked with a “(b)” followed by a number in parentheses. I’m normally a curious person, but it never occurred to me that those letters and numbers had a meaning. I had an aha (and color me red) moment [...]

66 New FDA 483s | April 23rd 2018

In the past 2 weeks we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free trial of the leading GMP intelligence newsletter. Like This & Want More? Sign up to get free weekly content updates designed to make your [...]

A Look Into the Foreign Food Facility Inspection Program

Due to a recent push by the FDA for more foreign food inspections, it is important that all foreign facilities are up to par. No matter what capacity they contribute in (packing, processing, or holding food) these facilities are subject to inspection by the FDA. It can be difficult to navigate new requirements for foreign facilities under FSMA, but [...]

By | 2018-04-19T15:36:57+00:00 April 19th, 2018|cGMP Quality Assurance and FDA 483s, FDAzilla, Food, FSMA|